CMS Proposes Major Updates to Prior Authorization for Drugs

On April 10, 2026, CMS released a proposed rule (CMS-0062-P) that would significantly expand electronic prior authorization requirements to include drugs covered under both medical and pharmacy benefits and establish new decision timeframes for drug PA requests across Medicare Advantage, Medicaid, CHIP, and qualified health plans. The rule would also require payers to provide specific reasons for drug PA denials and publicly report PA metrics. A key Request for Information seeks stakeholder input on streamlining step therapy through technology and data sharing.

For mental health clinical research sites, these changes have real implications, particularly around step therapy requirements that can delay patient access to the right treatment. Now is the time to engage — your clinical experience is exactly the voice CMS needs to hear from.

CMS is accepting comments on or before June 15, 2026 at 11:59 PM EDT

*See below right for sample submission with letter attachment.

Here is a table of some of the issues with the Proposed Rule and why your voice matters:

Issue What the rule does Why your voice matters
Denial reasons lack teeth Requires payers to give a “specific reason” for drug PA denials — but does not define what that means or distinguish procedural from substantive denials. Without stronger standards, payers can satisfy the requirement with vague language like “step therapy not met” — revealing nothing about the clinical judgment behind the denial.
New patients face step therapy for antipsychotics The Part D protected class policy prohibits step therapy for established patients — but permits it for new starts, including patients newly diagnosed or new to a plan. Early treatment decisions in psychotic illness are among the most consequential in psychiatry. A failed medication trial can trigger relapse with lasting consequences.
Injectable antipsychotics under Part B have no protection The protected class policy applies only to Part D. Long-acting injectable (LAI) antipsychotics — covered under Part B — have no step therapy safeguards in Medicare Advantage. LAIs are clinically essential for many individuals with schizophrenia who struggle with oral adherence. This gap is largely invisible in public discourse — organizations serving this population are best positioned to raise it.
Existing protections are under pressure Cost-containment initiatives like the GUARD model risk eroding formulary protections for protected class drugs, including antipsychotics, even for established patients. The protected class framework requires active defense. Rulemaking comments create a public record CMS must consider. Silence signals that existing protections can be quietly weakened.
Step therapy technology RFI CMS is soliciting input on using technology to streamline step therapy — including whether prior payer determinations should carry over when patients switch plans. Without mental health advocates weighing in, this RFI will be shaped by payer and health IT voices. Technology that automates step therapy without psychiatric exemptions could accelerate harm at scale.
Deadline: June 15, 2026 Submit comments electronically at regulations.gov. Reference file code CMS-0062-P. A full comment letter can be attached as a PDF. CMS weighs the volume and specificity of public comments. Even a brief, focused submission from your organization adds to the record.

*Want more help with your submission? Check out our submitted comments in the right-hand column, under the box → →

    • On April 10, 2026, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule on Interoperability Standards and Prior Authorization (PA) for Drugs.1

    • This proposed rule includes five standalone Requests for Information (RFIs) that are distinct from the policy proposals.1

    • CMS is accepting comments on or before June 15, 2026 at 11:59 PM EDT2

Summary of PA & Step Edit Proposals

Proposals would apply to the following payer types1:

    • Medicare Advantage (MA) organizations

    • State Medicaid and Children’s Health Insurance Program (CHIP) fee‑for‑service (FFS) programs

    • Medicaid and CHIP managed care plans

    • Qualified Health Plan (QHP) issuers on the Federally‑facilitated Exchanges (FFEs)

    • Small‑group QHP issuers on the Federally‑facilitated SHOP (FF‑SHOP) (newly included)

The proposals in the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule (CMS-0062-P), described in the table below, would enhance transparency of prior authorization requirements, allowing for faster and more informed care decisions. (summary)

KEY PROVISION CURRENT POLICY PROPOSED POLICY CHANGE
Electronic Prior Authorization for Drugs1 Requires impacted payers to support electronic prior authorization for non-drug items and services via the Prior Authorization API (the 2024 final rule)3 Would require impacted payers to incorporate coverage and documentation requirements for drugs covered under a medical benefit into the Prior Authorization API. Would require impacted payers to support electronic prior authorization for drugs covered under a pharmacy benefit using certain National Council for Prescription Drug Programs (NCPDP) standards.2
Prior Authorization Timeframes1 Requires MA organizations, state Medicaid and CHIP FFS programs, Medicaid managed care programs, and CHIP managed care entities to make prior authorization decisions on non-drug items and services within 7 calendar days for standard requests and 72 hours for expedited requests (the 2024 final rule). QHP issuers on the FFEs are not subject to the timeframes established in the 2024 final rule; rather they must provide patients with notice on prior authorization decisions regarding non-drug items and services within certain established timeframes in 45 CFR 147.136(b)(3)(i).3 Would require that QHP issuers on the FFEs provide notice to the requesting provider of prior authorization decisions on non-drug items and services as expeditiously as the enrollee’s health condition requires, but no later than 7 calendar days after receiving a standard request and no later than 72 hours after receiving an expedited request. Would require that impacted payers make prior authorization decisions on all drugs within certain timeframes.2
Require a Specific Reason for Denying a Prior Authorization Request for Drugs1,2 Requires impacted payers to include a specific reason for denying a prior authorization request for non-drug items and services (the 2024 final rule).3 Would require impacted payers to include a specific reason to providers for denying a prior authorization request for all drugs.2
Publicly Report Prior Authorization Metrics1 Requires impacted payers to publicly report certain prior authorization metrics on non-drug items and services (the 2024 final rule).3 Would require impacted payers to publicly report additional prior authorization metrics on non-drug items and services. Would require impacted payers to publicly report certain prior authorization metrics on all drugs (excluding covered Part D drugs for Medicare Advantage-Prescription Drugs [MA-PDs]).2

Requests for Information (RFIs)

CMS will collect public responses to RFIs regarding this proposed rule to analyze and determine steps the agency can take to improve related issues in the healthcare industry. One key RFI out for stakeholders is Step Therapy.

    • CMS also seeks comments on ways to streamline the step therapy process through technology and data sharing (such as the Payer-to-Payer API) to allow payers access to historical patient information. CMS seeks comments on how technology may facilitate step therapy determinations and improve current step therapy processes. This includes the role of technology in evaluating and applying step therapy use criteria and how payers evaluate and honor step therapy use criteria from other payers.1

What’s next? Comments on the proposals must be submitted by June 15, 2026 at 11:59 PM EDT.  To submit comments or questions electronically, go to www.regulations.gov, enter the docket number “2026-07205” in the “search” field, and follow the instructions for ‘‘submitting a comment”.2

Advocates, patients, caregivers, and community organizations all have standing to comment. Personal, real-world perspectives on how prior authorization and step therapy requirements affect access to mental health treatment are exactly what CMS needs to hear.

Reference file code CMS-0062-P in your submission.

Notes and References:

1.CMS, Fact Sheet: 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (April 2026), https://www.cms.gov/files/document/fact-sheet-medicare-drug-price-negotiation-program-ipay-2027-and-manufacturer-effectuation-mfp-2026.pdf.

2.CMS. Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children’s Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges Proposed Rule. (April 2026). Federal Register :: Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children’s Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges

3. CMS. Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children’s Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program. (February 2024). https://www.federalregister.gov/documents/2024/02/08/2024-00895/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-advancing-interoperability

CMS Prior Authorization Proposed Rule: Good, Bad, or Both?

Both, actually — that’s what makes this rule nuanced.

The Potentially Good Parts

Faster decision timeframes mean patients wait less time for approval

Requiring specific reasons for denials gives providers and patients something to actually appeal against — right now, vague denials are a major barrier

Electronic PA standardization reduces administrative burden on clinical sites

Public reporting of PA metrics creates accountability for payers

The Potentially Concerning Parts

Expanding electronic PA to drugs means more drugs now fall under the PA system — which could mean more treatments require prior authorization than before

Step therapy requirements, while being examined for streamlining, still remain a mechanism that can force patients through medication trials before accessing the treatment their provider actually prescribed

For antipsychotics specifically — where the clinical community holds a strong position that these medications are not interchangeable — any step therapy framework that treats them as substitutable carries real clinical risk

The Bottom Line

The rule modernizes and speeds up a system that still has fundamental problems. Faster and more transparent isn’t the same as less burdensome. That’s precisely why the comment period matters — advocates can affirm the transparency wins while pushing back hard on step therapy provisions that could harm patients with serious mental illness.

Comments are due June 15, 2026. Submit via regulations.gov using file code CMS-0062-P.

Download the STARR comments submitted to CMS
(Comments are limited to 5,000 characters):

Download the STARR letter submitted to CMS
(supplement to limited comments):